FIRST STEPS – a randomized controlled trial on the evaluation of the implementation and effectiveness of two early prevention programs for promoting the social integration and a healthy

The social integration of children with an immigrant background has become one of the most urgent social responsibilities in Germany. They are more likely to live in high-risk environments and are disadvantaged with respect to health related variables as well as educationally.

S T U D Y P R O T O C O L Open Access

on the evaluation of the implementation

and effectiveness of two early prevention

programs for promoting the social

integration and a healthy development of

children with an immigrant background

Judith Lebiger-Vogel1, Constanze Rickmeyer1, Annette Busse1, Korinna Fritzemeyer1, Bernhard Rüger2

and Marianne Leuzinger-Bohleber1*

Abstract

Background: The social integration of children with an immigrant background has become one of the most urgent social responsibilities in Germany They are more likely to live in high-risk environments and are disadvantaged with respect to health related variables as well as educationally Quite a number of projects supporting their integration into the German society exist although many are hardly scientifically evaluated Most of them focus on the acquisition of German language and therefore address older children (and adults) However, international experts agree that social integration is not only a matter of language but also of earlier developmental processes of children in their first months

of life connected to adequate early parenting

Methods/Design: The model project FIRST STEPS focuses on earliest prevention for children with an immigrant background, supporting their parents in the critical phase of migration and early parenthood In a prospective

randomized comparison group design the effectiveness of a psychoanalytically oriented early prevention program (intervention A) is compared to the outcomes of groups offered by paraprofessionals with an immigrant background (intervention B) Intervention A is a professional offer supporting immigrant families based on developmental

psychological and on knowledge on early parenting 180 families are randomly assigned to intervention A or B They are supported during the first 3 years of the children’s lives Social and family stressors, the quality of the parent–child-interaction, child attachment security, the affective, cognitive and social-emotional development of the children and the social integration of the families are assessed during and after the intervention

(Continued on next page)

* Correspondence: m.leuzinger-bohleber@sigmund-freud-institut.de

1

Sigmund-Freud-Institut, Frankfurt/Main, Germany, University of Kassel, Kassel,

Germany

Full list of author information is available at the end of the article

© 2015 Lebiger-Vogel et al This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited The Creative Commons Public Domain Dedication waiver (http://

(Continued from previous page)

Discussion: The project aims at evaluating the implementation as well as the short- and long-term effectiveness

of psychoanalytically oriented intervention A compared to the outcomes of intervention B It is expected that professionally supported early parenting (intervention A) improves the social-emotional, cognitive and language development of immigrant children as well as the social integration of their families to a greater extent than in the comparison groups In case the model project proves to be effective, a rollout across Germany is possible Due to the“difficult-to-reach” immigrant families challenges in recruitment, uptake and retention of participants are anticipated

Trial registration: DRKS-ID: DRKS00004632, trial registration date: 05.02.2013

Keywords: Psychoanalysis, Early prevention, Immigrant background, Migration, Integration, Parent

–child-relationship, Early parenting, Attachment, Child development

Background

Children with an immigrant background are still

disad-vantaged concerning health related variables such as

Schaffrath Rosario 2007; Hölling et al 2008; Rattay et al

2012; https://www.bmas.de/SharedDocs/Downloads/DE/

PDF-Publikationen-DinA4/a334-4-armuts-reichtums-bericht-2013.pdf? blob=publicationFile; Autorengruppe

Bildungsberichterstattung 2012), their educational

achieve-ment and are more likely to live in high-risk environachieve-ments

(Sachverständigenrat deutscher Stiftungen für Integration

und Migration (SVR) GmbH: Deutschlands Wandel zum

modernen Einwanderungsland Jahresgutachten 2014;

Leuzinger-Bohleber et al 2006; Leuzinger-Bohleber et al

the immigrant background per se that puts these children

at risk of becoming disadvantaged but it is rather the

fac-tors that are associated with their parents´ migration,

psy-chological factors due to the different phases of migration

and socio-economic factors (low socio-economic status,

unemployment, insecure institutional status etc.) that

cre-ate difficult developmental environments for these

chil-dren Children of mothers who have not lived in Germany

for a long time are particularly disadvantaged, because the

mothers are in an emotionally insecure situation

them-selves They have to get along in a new surrounding while

during the vulnerable time after the birth of a child the

mothers often feel alone and isolated and the risks of

so-cial withdrawal, isolation and depression are significant

emotional quality of the early mother-child relationship

and attachment security and thus brings about an

add-itional disadvantage for the children, placing them in a

special risk group among the immigrant population

Results of the Frankfurt prevention study

(Leuzinger-Bohleber et al 2006; Leuzinger-(Leuzinger-Bohleber et al 2009;

Leuzinger-Bohleber et al 2011) indicated that a poor or

lacking early integration can be associated with a potential

migra-tion and young motherhood

their parents, especially their mother, suffer from severe

of immigration emotionally, they will perceive turning to the culture and language of the immigration country as

a betrayal and a turning away from their parents or mother Often this kind of loyalty conflict keeps children with an immigrant background from successfully learn-ing the language of the immigration country and inte-grating psychosocially (King 2007; Leuzinger-Bohleber

losses possibly leading to behavioural difficulties, school failure and/or depression if not processed thoroughly Especially findings from attachment research regarding disorganized attached children (Type D) are alarming

As known from longitudinal studies, children who show this kind of attachment style have the worst prognosis and will show aggressive-destructive behaviour, worse school achievement and massive psychological problems already during elementary school in all probability if they

do not receive early help and support (Lyons-Ruth et al 1993; Solomon et al 1995; Green and Goldwyn 2002; Moss et al 2004; Cassidy and Shaver 2008; Stacks and Oshio 2009) A notable number of these children come from families with an immigrant background, who due to factors which are often associated with migration such as experiences of violence in their home country, social isola-tion after marriage migraisola-tion and resp low social-economic status are severely stressed or even traumatized (Batista-Pinto Wiese 2010; Fazel et al 2005; Leuzinger-Bohleber 2012; Schechter and Rusconi Serpa 2014) Quite a number of projects, which promote the social integration of children with an immigrant background exist in Germany Most of them focus on acquiring the German language and thus address older children or adults (Friedrich and Siegert 2009; Lösel et al 2006) and

well-being Infants however, only begin to actively acquire

language during their second year of life and during

in-fancy learning their mother’s language is most

import-ant It is well known that the development of language is

from the beginning on Stern (1985) studied the different

stages of the development of the self and showed that

the earlier stages of this development (the emergent self,

the core self etc.) Thus integration approaches, which

solely focus on acquiring the German language, are

lim-ited to this aspect and are not effective for children

between the age of zero and three (infants and toddlers)

Some of the already existing projects supporting

chil-dren with an immigrant background have been evaluated

The quality of these evaluations can however often be

regarded as problematic and the effectiveness of programs

conducted by lay helpers with an immigrant background

has often not been thoroughly explored (Friedrich and

Siegert 2009; Lösel et al 2006) In addition many projects

deploy lay helpers although the outcome of early

preven-tion projects seems to be positively influenced by the

pro-fessionalism of staff (Olds et al 2008; Holodynski et al

2007) Systematic integration projects with the goal to

optimize the first environmental and relationship

experi-ences of children with an immigrant background are

scarcely evident in Germany However research findings

strongly suggest such an approach, because infants, who

grow up in a positive and emotionally secure environment

are more creative, show less aggression, show better

cog-nitive, affective and social-emotional development and

learn languages more easily (Aviezer et al 2002; DeKlyen

and Greenberg 2008; Fearon et al 2010; Sroufe et al 2005;

Thompson 2008; Van IJzendoorn et al 1995) Therefore

one can assume that approaches which take early

relation-ships within the direct living environment as a starting

point (during this age particularly the core family), could

also improve integration of children with an immigrant

background during infancy and toddler age Furthermore,

language acquisition as well as the development of

com-municative, social competencies cannot fully be

under-stood if they are not viewed within the context of early

relationship experiences (Emde and Leuzinger-Bohleber

2014; Korntheuer et al 2010)

FIRST STEPS is a psychoanalytically oriented

preven-tion program for immigrant families offered from the

time of pregnancy until entering kindergarten It focuses

on the specific challenges and needs of families with an

immigrant background and seeks to optimize the early

developmental environment of children at risk of

grow-ing up disadvantaged due to their parents’ acute

migra-tion (and possible stress)

The project was conceptualized in the context of the

Sigmund-Freud-Institut (SFI; Frankfurt/Main) in collaboration with the Anna-Freud-Institut (Frankfurt/Main) IDeA represents a large, interdisciplinary research center, a co-operation between the Goethe University Frankfurt, the German Institute for International Educational Research

programme fostering excellent research in the federal state of Hessen, Germany FIRST STEPS serves as a scientifically evaluated model project in the sense that its success would enable the implementation in other communities and cities in Germany, independently from regional specificities such as the ethnic compos-ition of the immigration population, project staff and context of recruitment In a second step it is planned

to also implement FIRST STEPS in Berlin This offers the opportunity of testing the workability and practi-cality of dissemination, recruitment strategies and pos-sible needs for adaption of FIRST STEPS in another institutional context

Goals of FIRST STEPS

FIRST STEPS seeks to contribute to early prevention and improving the social integration as well as a healthy development of children coming from social marginal groups of society, which are hard-to-reach (see below)

In supporting mothers with an immigrant background and in promoting infant-mother (and father)

that FIRST STEPS will facilitate successful parent–child interaction from the time the natural window for its de-velopment opens In doing so, the project intends to promote attachment security and a positive child devel-opment As empirical attachment, neurobiological and epigenetic research show, attachment security is a pro-tective factor for cognitive, socio-emotional and lan-guage development as well as academic success (Berlin

et al 2008) Furthermore, it is expected that by promot-ing parents’ reflective functionpromot-ing (Fonagy et al 2002), adequate emotion regulation, processing of losses caused

by migration, parenting behaviour (e.g responding to their infant’s cues consistently) as well as cultural com-petencies parents’ and children’s psychosocial integration will be facilitated Negative primary (e.g poorly educated parents) and secondary family background related effects

on the child (Boudon 1974, e.g parental educational de-cisions when poorly informed about or afraid of the edu-cational system) would be weakened by this kind of support

In a prospective randomized comparison group design the project aims at evaluating the implementation as well as the short- and long-term effectiveness of FIRST STEPS (intervention A) in comparison to an interven-tion being offered by paraprofessionals (interveninterven-tion B)

A variety of instruments are applied at different times of

measurement during the intervention as well as

after-wards when the children attend kindergarten (follow-up;

see below)

Methods/Design

Participants, inclusion and exclusion criteria

FIRST STEPS addresses pregnant first-generation

immi-grant women (from the second trimester on, and their

husbands) who have no or little knowledge of the German

language and have not been living in Germany for longer

than 3 years (in accordance with the population of the

in-tegration courses, see Rother N, http://www.bamf.de/

SharedDocs/Anlagen/DE/Publikationen/WorkingPapers/

wp19-Integrationspanel.pdf? blob=publicationFile) Most

of our participants have a low socio-economic status

means the participants often fail to access social and

community services (e.g family support services) and

therefore remain unprovided (Doherty et al 2004) It is

difficult to recruit this population and a lot of effort

is needed to get the participants to commit to the

prevention program and to stay involved over time

(Cooney et al 2007)

Recruitment

Participants are recruited in obligatory integration

courses (on German language and "culture") at three

dif-ferent regional non-profit social service centres in

Frankfurt/Main These courses were implemented

na-tionwide in 2004 and are part of the political reactions

to the clarion call of the early PISA studies and the late

realization that Germany has become an immigration

country but had mainly missed out on socially

integrat-ing its immigrants

Interventions/observational groups

The FIRST STEPS study compares two prevention

pro-grams which are both offered from the time of

preg-nancy until entering kindergarten: A broader, more

individual and complex psychoanalytically oriented

intervention, the FIRST STEPS intervention (A) and a a

less complex standard intervention being offered by

paraprofessionals (B)

Intervention A - FIRST STEPS

The psychoanalytically trained FIRST STEPS project

staff, mostly mothers with an immigrant background

themselves, support the women (and their husbands)

ideally already during pregnancy Hence they build an

emotional relationship with them in order to continue

their support after the birth of the child This support

should help the women to avoid withdrawal into

isolation Afterwards the project staffs continue to

accompany and support mothers and children both in group contacts (moderated weekly groups with two pro-ject staff members) and individual contacts (via tele-phone, home visits) until the children enter kindergarten

at the age of around three The FIRST STEPS approach

is curriculum-based The training of the project staff includes psychoanalytic case-supervision, practice reflec-tion with the coordinator of the practical

adolescent psychotherapists The manualised curricu-lum, which has been developed by the coordinator of the practical implementation, is based on psychoanalytic and empirical developmental psychology and will be published in the near feature The conceptualisations closely refer to other already evaluated psychoanalytic-ally oriented parenting programs (Emde and Robinson 2000; Meurs et al 2006; Parens et al 1995) The training sensitizes staff for the processes of transference and counter-transference allowing for a deeper understand-ing of the women’s situation and children’s needs The

“mind-set” and to create a holding and containing function (Bion 1963) in contact with the individual women as well as during the group sessions Thus they can serve

325) for the mothers, supporting them in the vulnerable phase of their early motherhood Their consultation fo-cuses on individual needs of the mothers and children as well as questions and concerns the families might have concerning the child’s development The project staff thereby supports parenting competences (e.g reflective functioning, adequate emotion regulation) Furthermore, questions concerning migration problems of the families (supporting them to consult institutions, clinics, social and mental health care services, language courses, edu-cational institutions etc.) are addressed Coping with losses associated with the women’s and families’ migra-tion is supported

Intervention B

The mothers and children in intervention B take part in

are mostly mothers themselves, pass on their experi-ences to the mothers and invite for social exchange The paraprofessionals are only instructed and informed about the study very basically, including the aimed duration of the intervention until children enter kinder-garten and research instruments, and are free to conduct and organize their groups according to their views and their experience as immigrants and mothers They do not receive any support with regard to contents and have no contact with the project organization and

implementation other than with the research team

col-lecting data about mothers and children

Assessments

A variety of instruments are applied at five different

times of measurement; four in the course of the

inter-vention, one directly afterwards, when the children enter

kindergarten (t2: 2,5-5 months, t3: 13–15 months, t4:

24–27 months, t5: 36–39 months) and one time of

measurement after the intervention, when the children

attend kindergarten (t6: 8–14 months after kindergarten

entrance)

Sociodemographic information of the families

(base-line assessment, t1) is assessed at the beginning of the

intervention by using a self-report questionnaire, which

was developed by the Bundesamt für Migration und

Flüchtlinge (BAMF, German Federal Office for

com-plemented by an additional set of questions concerning

the mother’s integration called the Hertie Belonging

Scale, a scale developed by the research team

Further-more, the project staff evaluates family stressors and

so-cial support of the families during the course of the

intervention by using the Heidelberger Belastungsskala

(HBS-L) (Stasch 2009), a standardized screening scale

In addition the mothers’ subjective daily stressors and

life-satisfaction are assessed twice (t4 and t5) using a

self-report questionnaire, the Everyday Stressors Index

(ESI, Jäkel and Leyendecker 2008) Mothers’ depressive

symptoms are assessed after birth (t2) with a self-report

questionnaire, which is used as a screening instrument

for post-partum depression The mothers are asked to

fill in the ADS Scale (Allgemeine Depressionsskala,

Hautzinger and Bailer 2002) with the help of the project

staff The cognitive and motor development of the

chil-dren are assessed by trained psychologists at age 2 (t4)

using the German version of the Bayley Scales of Infant

Development II (Reuner et al 2007) Furthermore, the

emotional quality of mother-child interaction is assessed

at four different times of measurement (t2, t3, t4 and

t5) Therefore videotaped mother-child interactions are

blindly rated by independent and trained psychologists with

the help of the Emotional Availability Scales (Biringen Z,

http://emotionalavailability.com), an observational

instru-ment with a dyadic focus

After the intervention, when the children enter

kinder-garten (t5) an Integration Questionnaire (including the

Hertie Belonging Scale) is applied in order to gain

infor-mation on the mothers’ successful participation resp

continuation of the integration/language courses and the

mothers’ integration Furthermore, the mothers’

satisfac-tion with the intervensatisfac-tion is assessed with the help of a

half standardized questionnaire in form of an interview

In addition, the children’s stress level, socio-emotional

as well as language development is assessed during follow-up Thereby the children’s hair cortisol level is measured as a marker of stress when the children enter kindergarten (t5), 6 weeks afterwards as well as 1 year later (t6) Furthermore, the kindergarten teachers evalu-ate the children’s behaviour (aggressiveness, hyperactiv-ity, anxiety and social competence) using the Strengths and Difficulties Questionnaire (SDQ, Becker et al 2004a; Klasen et al 2000; Woerner et al 2002; Woerner et al 2004) a year after entering kindergarten (t6) Also at t6 the children’s attachment security is assessed by trained and independent psychologists with the help of the Manchester Child Attachment Story Task (MCAST) (Green et al 2000) At about the same time (t6) the children’s German language development is assessed by trained linguists with the help of the LiSe-DaZ (Linguistic

Lan-guage, Schulz and Tracy 2011) This is a standardized lan-guage test, which is conceptualized and standardized for children who learn German as a second language The assessed variables and times of measurement are pre-sented in Fig 1

Objectives and hypotheses

The purpose of the trial is to address the following issues:

Differential short and long-term efficacy of two prevention programs (interventions A & B) for children with an immigrant background and their mothers and

Course and stability of prevention effects

The hypotheses assume that FIRST STEPS (interven-tion A), which individually addresses the families´ particular needs, is more effective compared to the inter-vention being offered by paraprofessionals (interinter-vention B) concerning the following outcomes

The first set of hypotheses assumes that it is more ef-fective in terms of the children’s development

Hypotheses on primary outcome

The primary outcomes will be measured shortly after entering (t5) and after 1 year of kindergarten (t6) Hypothesis 1: When entering kindergarten (t5) and after 1 year in kindergarten (t6) the children in interven-tion A show lower levels of stress compared to the chil-dren in intervention B (cortisol level measured by hair cortisol)

Hypothesis 2: After 1 year in kindergarten (t6) the chil-dren in intervention A show a better language development compared to the children in intervention B (measured

by the Linguistic Language Development Survey –

German as Second Language, LiSe-DaZ)

Hypothesis 3: After 1 year in kindergarten (t6) the

chil-dren in intervention A show a better socio-emotional

development compared to the children in intervention B

(measured by the Strengths and Difficulties

Question-naire, SDQ)

Hypotheses on secondary outcome

Hypothesis 4: At time of measurement t4 the children in

intervention A show a better cognitive and motor

devel-opment compared to the children in intervention B

(measured by Bayley Scales of Infant Development II)

Hypothesis 5: At time of measurement t5 the children

in intervention A show a better relationship to their

pri-mary caregiver (mother) compared to the children in

mea-sured by the Emotional Availability Scales, EAS)

Hypothesis 6: The children in intervention A show

after 1 year in kindergarten (t6) more often a secure

at-tachment style (Type B) compared to the children in

intervention B (measured by the Manchester Child

Attachment Story Task, MCAST)

The second set of hypotheses assumes that

interven-tion A is more effective in terms of the mothers’

psycho-social integration and language development than

intervention B

Hypotheses on primary outcome

Hypothesis 7: At time of measurement t5 more mothers in intervention A successfully have completed the integration course in comparison to those in intervention B (measured

by the Integration Questionnaire with repeated assessment

of questions of the BAMF questionnaire) Hypothesis 8: At time of measurement t5 the mothers

in intervention A are socially more oriented towards the host country, in comparison to those in intervention B (measured with the Hertie Belonging Scale)

Hypotheses on secondary outcome

Hypothesis 9: At time of measurement t5 the mothers in intervention A show a higher satisfaction with the inter-vention in comparison to the mothers who took part in intervention B

Design

Figure 2 summarizes the study design The individual participants (children and their parents) were not aware of their group assignment, that is, if they were participating

in intervention A (FIRST STEPS) or in intervention B The integration courses which the women are attending are randomly assigned to the two different interventions

A and B, because women from the same integration course cannot be referred to different interventions (cluster-randomization)

T3

T4

T5

T6

BAMF-FB

(Socio-demo-graphic data, incl Hertie-Belonging Scale)

HBS-L

(Family stressors and social support)

EAS

(Video of mother-child interaction)

ADS

(Depressive symptoms

of mother)

EAS (Video) EAS (Video)

Bayley Scales

(Cognitive and motor develop.)

ESI I

(Parenting stress )

EAS (Video) ESI II Mothers’

satisfaction Integration Questionnaire

(incl Hertie-Belonging Scale)

Haircortisol I and II

Haircortisol III SDQ

(Socio-emotional development

Lise-DaZ

(Language acquisition)

M-CAST

(Attachment)

Pregnancy – 1,5 months

2,5 – 5,5 months

13 – 15 months

24 – 27 months

36 – 39 months Follow-up

Fig 1 Timeline of assessed variables and times of measurements Legend: BAMF-FB: Questionnaire from the Federal Office for Migration and Refugees; Hertie-Belonging Scale: half standardized rating form – information on the mothers’ integration; HBS-L: Heidelberger Belastungsskala (scale on family stressors and social support); EAS: Emotional Availability Scales; Bayley: Bayley Scales of Infant Development II; ADS: Center for Epidemiologic Studies-Depression Scale; ESI: Everyday Stressors Index; Integration Questionnaire: Half standardized rating form – information on the mothers ’ successful attendance of the integration course and integration (including selected BAMF items and the Hertie Belonging Scale); SDQ: Strengths and Difficulties Questionnaire; LiSe-DaZ: Linguistic Language Development Survey – German as Second Language; MCAST: Machester Child Attachment Story Task

Primary outcome

1 One primary outcome criterion is the stress level of the

childrenmeasured by the children’s hair cortisol level a

week before kindergarten entrance, 6 weeks afterwards

as well as 1 year afterwards Measuring the

concentration of cortisol in hair is a new and promising

method to measure cortisol (Stadler and Kirschbaum

2012) For many years cortisol was obtained primarily

from blood plasma or urine, whereas later approaches

added saliva and feces for non-invasive monitoring of

HPA functioning These methods are limited in the

temporal range of assessment and are only snapshots

of HPA activity However being incorporated into the

growing hair, hair cortisol concentrations are assumed

to provide a retrospective reflection of integrated

cortisol secretion over periods of several months

(Stadler and Kirschbaum2012) Over the past years

supportive evidence has accumulated regarding

several fundamental characteristics of hair cortisol

concentrations, including its validity as an index of

long-term systemic cortisol levels both in animals

(Fairbanks et al.2011) and in human participants

(Manenschijn et al.2011), its reliability across

repeated assessments (Stadler et al.2012) and its

relative robustness to a range of potential confounding

influences (Stadler and Kirschbaum2012)

2 Another primary outcome criterion is the children’s

knowledge of the German language, assessed a year

after kindergarten entrance by a trained linguist

with the help of the LiSe-DaZ (Linguistische Sprachstandsdiagnostik - Deutsch als Zweitsprache, Schulz and Tracy2011), a standardized language test Language acquisition is critical for the children’s later school success (Gantefort and Roth

2010; Niklas et al.2011) The LiSeDaZ enables to measure children’s development in core grammatical areas and offers separate norms for multilingual children, which take into account the age of first exposure and the length of exposure to the German language (Schulz and Tracy2011)

3 A third primary outcome criterion is the children’s socio-emotional development, evaluated at

kindergarten age by kindergarten teachers using the Strengths and Difficulties Questionnaire (SDQ, Becker et al.2004a) With the help of the SDQ the following subscales can be assessed: prosocial behavior, hyperactivity, emotional problems and conduct problems with peers The SDQ is not only a practical and economical, but also a valid and reliable questionnaire for use in the framework of a multi-dimensional behavioural assessment, and appears to be well suited for screening purposes, longitudinal monitoring of therapeutic effects, and scientific research purposes (Becker et al.2004b; Klasen et al.2000; Woerner et al.2002)

4 A fourth primary outcome criteria on the part of the mothers is the mother’s integration (among others mothers’ successful completion of integration courses, employment/occupational comeback, interest in host country), measured by the repeated assessment of a part of the BAMF questionnaire and the Hertie Belonging Scale at the end of the

intervention as indicators of successful integration

Secondary outcomes

The secondary outcomes are:

1 The children’s cognitive and motor development, assessed by trained psychologists at age 2 (t4) using the German version of the Bayley Scales of Infant Development II (BSID, Reuner et al.2007) The BSID II evaluates infants along three scales: a cognitive, a motor and a behaviour scale The scales have been used extensively worldwide to assess the development of infants and are known to have high reliability and validity (Vohr et al.2012)

2 The emotional quality of the of mother-child interaction, assessed at four different times of measurement (t2 to t5) by independent and trained psychologist using the Emotional Availability Scales (EAS,http://emotionalavailability.com) The EAS allow for a detailed look at caregiver-child interactions

by rating the dyad on six dimensions, four focusing on

Sample size: N = 90

Mothers giving birth in

time frame

After Drop Outs: N = 72

Baseline of all integration courses in

Frankfurt

Integration Courses with Child Care

Integration Courses of the Institutions

Group A Prevention Group Group B Prevention Group

Randomisation per Course

Total Collection Total Collection

Sample Size N = 90

Mothers giving birth in time frame

After Drop Outs: N = 72

Fig 2 Research design

the parent’s behaviour (sensitivity, structuring,

non-intrusiveness, non-hostility) and two focusing on

the child’s behaviour (child responsiveness, child

involvement of the caregiver) Significant findings

have been reported about the positive relationship

between parental EA and children’s attachment

security (Biringen2000) and there is a large body of

empirical research using the EA Scales (Biringen

et al.2014) It is of particular relevance that the

EAS dimensions can be rated independently of the

caregivers’ cultural background (Biringen2009;

Biringen et al.2014) Ziv et al (2000) for example

reported cross-cultural applicability of the EAS by

examining links with attachment In addition the

EAS are an instrument that is sensitive to change

related to a program of intervention (for an

overview see Biringen et al.2014)

3 The children’s attachment style, assessed by trained

psychologists using the MCAST (Green et al.2000)

1 year after entering kindergarten (t6) The MCAST,

a narrative story stem task that involves playing with

dolls, is a validated, structured measure that

evaluates young children’s attachment

representations through the use of play scenarios

allowing for differentiation between four overall

attachment classifications: secure attachment,

insecure-ambivalent attachment, insecure-avoidant

at-tachment und insecure-disorganized atat-tachment

representations

4 The mothers’ satisfaction with the intervention,

assessed after the intervention by using a

half-standardised questionnaire in form of a resumeé

interview at t5

Sample size calculation - power analysis

The sample size calculation resp power analysis is

concerning the number of participants in the language

courses Concerning the different primary outcomes

(children’s stress level, language development,

socio-emotional development and mothers’ integration) we

expect effect sizes of at least d = 0.5 Then the sample

size for analysis of variance in a RCT study would be

n = 63 But we applied a CRCT study Therefore we

have to correct the n in a corrected n* according to the

following formula introduced by Eldridge et al (2006),

providing a conservative estimate of sample size

requirements for trials using cluster-level analyses

weighted by cluster size:

n  ¼ f1 þ ½ð1þ CV2Þ x m – 1 xICCg x n

The formula consists of the coefficient of variation CV

for trials with unequal cluster sizes (that means with

unequal sizes of language courses) and the intraclass-correlation coefficient ICC within the clusters and the mean cluster size m Using the findings of a pilot study, the estimated coefficient of variation is CV = 0.4 (rather smaller) and the estimated intra class correlation coeffi-cient (based on the pre-post differences including the CV) ICC = 0.1 (rather smaller) Furthermore, we expect

a mean cluster size of m = 2 pregnant women in each course (cluster)

The corrected sample size would therefore be n* = 1.132 × 63 = 71.32 Thus the minimum sample size would be 72 pregnant women per treatment and resp

36 integration courses should be selected per treatment However under consideration of a 20 % drop-out rate the corrected minimum sample size is n* = n* × 1.25 =

90 women per treatment and thus a number of 45 courses per treatment should be selected (see Fig 2)

Representativeness of the sample and sample selection (at cluster level)

To control for internal representativeness homogeneity tests are applied in order to verify that the two treatment groups are homogenous and in order to test for poten-tial bias due to drop-outs or missing values To prove that our sample is similar to the German population of immigrants that take part in integration courses nation-wide (control of external representativeness) the BAMF questionnaire is applied

Randomization

As Fig 2 shows, randomization was performed at cluster level (integration course) A cluster-randomization was applied instead of a single randomization, because women from the same integration course should be assigned to the same intervention and not to different interventions The statisticians, uninformed about the identity of the integration courses, used a table of ran-dom numbers for ranran-domizing the 90 integration courses included in the study Individual participants (children and their parents) were not aware of their group assignment, that is, if they were participating in the psychoanalytical intervention or the intervention provided by paraprofessionals

Statistical analysis

The design is an analysis of variance design with re-peated measures The main instruments for analysis ap-plied are Analysis of variance (ANOVA) as well as Analysis of covariance (ANCOVA) models The main factor is the intervention group (A or B) and the most relevant secondary factor is the initial value (baseline value) All baseline characteristics will be described at the individual level Relevant characteristics will be added if

applicable as covariates to the models Six main

assess-ments encompass the treatment phase and follow-up

Ethical issues

The Ethic Review Commission of the Federal Chamber

of Psychotherapists of the State of Hessen, Germany, has

approved the final study protocol and the final version

of the written informed consent form Written consent

was obtained from each participating family The trial

will be carried out in keeping with local legal and

regula-tory requirements

Discussion

This trial has one major goal: to compare the effectiveness

of two different interventions on the development of

chil-dren with an immigrant background in Germany and the

integration of their mothers Based on empirical findings

it is expected that professionally supported good early

re-lationship experience improves long-term integration of

immigrant children In a prospective randomized

com-parison group design the project aims at evaluating the

implementation as well as the short- and long-term

effectiveness of FIRST STEPS (intervention A) in

com-parison to an intervention being offered by

paraprofes-sionals (intervention B) Anticipated is that supporting

the earliest parent-child-interactions and parenting

cap-acities in a professional psychoanalytically oriented

inter-vention (A) will have a greater positive impact on the

mothers’ integration, on children’s affective,

socio-emotional and cognitive development and on the quality

of the parent-child relationship than the intervention

pro-vided by paraprofessionals with an immigrant background

reach comparable doses of intervention in the course of

the 3 years of intervention for ensuring that effects would

be caused by the type of intervention and would not just

be a matter of more or less intervention

In any case, number and timing of group sessions and

individual contacts will be documented In this trial, a high

quality is assured by an independent assessment Due to

the high expected attrition rate in this population at risk,

drop-out is thoroughly documented and respective

analyses are being planned

As mentioned before, high quality evaluation of

pre-vention projects for young children with an immigrant

background and their families have been scarce and to

our knowledge an RCT comparison group design is

non-existent in Germany Thus the study has the status of a

model project If the prevention offers prove to be

effect-ive and sustaining, the empirically based prevention

pro-grams may be implemented in other German cities and

migrant populations as well Thus the study will prove

to have a practical and political relevance

Endnotes

1

In 2010 48 % of children living in families with a mi-grant background grew up exposed to at least one situ-ation of risk such as unemployed, low-income or educationally disadvantaged parents

2 IDEA = Individual Development and Adaptive Educa-tion of Children at Risk; http://www.idea-frankfurt.eu/ de

3

At this point about 120 researchers from different disciplines such as pedagogics, psychology, psychoanaly-sis, neurosciences and different subject didactics work together at the center Around 50 different research pro-jects are realized

Wissenschaftlich-ökonomischer-Exzellenz (Political strategy of the State

of Hessen for strengthening the development of scien-tific and economic excellence)

5 Child and youth-psychoanalyst Claudia Burkhardt-Mußmann (in Frankfurt) and Rose Alheim (in Berlin) 6

Self-organized open mother-child groups have be-come a common form of similar early prevention pro-jects in Germany (Friedrich & Siegert 2009)

7 This survey gives a broad overview over the personal background of the participants, the already acquired lan-guages and especially German language skills, job and educational issues and their life in Germany It has been used in a large scale study for the population of the inte-gration courses in Germany

Abbreviations ADS: Allgemeine Depressionsskala; ANCOVA: Analysis of covariance; ANOVA: Analysis of variance; BAMF: Bundesamt für Migration und Flüchtlinge (German Federal Office for Migration and Refugees); BSID: Bayley Scales of Infant Development; DIPF: Deutsches Institut für internationale pädagogische Forschung (German Institute for International Educational Research); EAS: Emotional Availability Scales; ESI: Everyday Stressors Index; HBS-L: Heidelberger Belastungsskala (scale on family stressors and social support); IDeA: Individual Development and Adaptive Education of Children at Risk; LiSe-DaZ: Linguistische Sprachstandserhebung – Deutsch als Zweitsprache (Linguistic Language Development Survey – German as Second Language); LOEWE: Landesoffensive zur Entwicklung wissenschaftlich-ökonomischer Exzellenz (Political strategy of the State of Hessen for strengthening the de-velopment of scientific and economic excellence); MCAST: Manchester Child Attachment Story Task; SDQ: Strengths and Difficulties Questionnaire; SFI: Sigmund-Freud-Institut.

Competing interests The authors declare that they have no competing interests.

Authors ’ contributions MLB is the Principal Investigator for this trial The study transcript was developed by MLB (design, concept for intervention “First Steps”), JLV (design, assessments), and BR (statisticians) JLV, CR, AB, KF and MLB managed the study, supervised research staff, enrollment and the follow-up of study participants JLV, CR, AB, KF and MLB drafted this manuscript BR analyzed study data as independent statistician JLV, CR, AB, KF, BR and MLB contributed equally to writing this manuscript and approving the final version.

Acknowledgements

We gratefully acknowledge the parents and their children in the FIRST STEPS project We would like to thank our following colleagues and co-workers in conducting the FIRST STEPS study: Claudia Burkhardt-Mußmann, Angelika

Wolff from the Ann-Freud-Institut, the AWO Hessen Süd, infrau e.V., ASB

Lehrerkooperative gGmbH, Hertie Foundation and IDeA Centre We would

particularly like to thank our consultants Prof Robert N Emde and Dr Henri

Parens for accompanying the research process and Prof Zeynep Biringen for

introducing the EAS to our research team.

Funding

First Steps is carried out by the Sigmund-Freud-Institut and the

Anna-Freud-Institut in the Center for Research on Individual Development and Adaptive

Education of Children at Risk (IDeA) which is supported by the “Landesoffensive

zur Entwicklung wissenschaftlich-ökonomischer Exzellenz (LOEWE) ” of the State

of Hessen, Germany (see: http://www.idea-frankfurt.eu/de), and additionally

funded by the Bundesamt für Migration und Flüchtlinge, by the state of Hessen,

Regierungspräsidium Darmstadt, by a private donator and the Hertie

Foundation.

Author details

1 Sigmund-Freud-Institut, Frankfurt/Main, Germany, University of Kassel, Kassel,

Germany.2Institute for Statistics, Maximilian University of Munich, Munich,

Germany.

Received: 29 January 2015 Accepted: 16 June 2015

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